Comitial Prophylaxis in Neurosurgery in Patients Who Have Undergone Intracranial Surgery Programmed Supratentorial Surgery (Exeresis or Biopsy) Between 2019 and 2022

NCT ID: NCT05670860

Last Updated: 2023-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-22

Study Completion Date

2023-05-22

Brief Summary

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JUSTIFICATION Anti-epileptic prophylaxis has long been a systematic practice for supra-tentorial intracranial surgeries. Since 2021, European guidelines no longer recommend this prophylaxis and practices have evolved.

We therefore propose to compare epileptic seizure's occurrence in the first postoperative month between two groups of neurosurgical patients.The first group consists of patients treated between January 2019 and late 2020 who were given systematic prophylaxis. Patients from the second group were treated between 2021 and 2022 and did not receive any prophylaxis.

The secondary objective will consist in identifying the number of patients placed on prophylaxis, the length of prophylaxis, treatment's side effects (depression, elevated liver enzymes…), and comparing patients' neurological outcome at 3 and 6 months after surgical procedures.

Detailed Description

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Conditions

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Anti-epileptic Prophylaxis in Intracranial Neurosurgery

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Anti-epileptic prophylaxis

The first group consists of patients treated between January 2019 and late 2020 who were given systematic prophylaxis

No interventions assigned to this group

NO Anti-epileptic prophylaxis

Patients from the second group were treated between 2021 and 2022 and did not receive any prophylaxis

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adults over 18 years old
* Expressed non-opposition
* Patient who underwent supratentorial intracranial surgery (either resection or biopsy) at Brest University Hospital from January 01, 2019 to September 01, 2022.

Exclusion Criteria

* Refusal to participate
* Patient under legal protection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Brest

Brest, , France

Site Status

Countries

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France

Other Identifiers

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29BRC22.0198

Identifier Type: -

Identifier Source: org_study_id

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